(46 days)
HemosIL Normal Control ASSAYED is intended for the quality control of coagulation assays in the normal range on IL Coagulation and ELECTRA™ Systems. The normal control is prepared using human citrated plasma from healthy donors. Values for all analytes are within the normal range.
HemosIL Normal Control ASSAYED is intended for the quality control of coagulation assays in the normal range on IL Coagulation and ELECTRA™ Systems. The normal control is prepared using human citrated plasma from healthy donors.
The provided text describes the HemosIL Normal Control ASSAYED device and its performance study. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for the within-run %CV. Instead, it presents the results of a precision study. For the purpose of this response, the "reported device performance" will be the "Within-Run %CV" from the study, and if acceptance criteria were explicitly stated, they would be listed alongside these values. Since they are not, we assume the presented values are deemed acceptable for substantial equivalence.
| Analyte | Reported Device Performance (Within-Run %CV) | Acceptance Criteria (Not explicitly stated in the document) |
|---|---|---|
| Activated Partial Thromboplastin (APTT) | 1.87 | N/A |
| Antithrombin | 2.10 | N/A |
| Factor V (Extrinsic) | 4.47 | N/A |
| Factor VIII (Intrinsic) | 6.36 | N/A |
| Fibrinogen - Clauss | 2.79 | N/A |
| Fibrinogen - PT-Based | 4.62 | N/A |
| Plasmin Inhibitor | 1.05 | N/A |
| Plasminogen | 1.38 | N/A |
| Protein C | 2.98 | N/A |
| Protein S | 1.84 | N/A |
| Prothrombin Time (PT) | 1.58 | N/A |
| Thrombin Time | 1.54 | N/A |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (n):
- For most analytes (APTT, Antithrombin, Factor V, Factor VIII, Fibrinogen - Clauss, Fibrinogen - PT-Based, Protein C, Prothrombin Time, Thrombin Time): n = 80
- For Plasmin Inhibitor, Plasminogen, Protein S: n = 40
- Data Provenance: The document states the control is "prepared using human citrated plasma from healthy donors." It does not specify the country of origin or whether the data was retrospective or prospective. Given the nature of a precision study for a control substance, it's highly likely to be prospective data collected specifically for this performance assessment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is a quality control material for coagulation assays, not an AI or diagnostic imaging device that requires expert review for ground truth. The "ground truth" for a control material is its expected value or range, established through rigorous manufacturing processes and internal validation, and compared against its own performance parameters (like precision). Therefore, these concepts of "experts establishing ground truth" are not applicable here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this is a quality control material, not a diagnostic or screening device that requires adjudication of expert opinions.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a quality control material and not a device that involves human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a quality control material, not an algorithm, and the performance described is intrinsic to the material itself and the analytical system it's used on.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a quality control material, the "ground truth" is typically established by:
- Manufacturing specifications: The intended concentration or activity levels of the analytes.
- Reference methods/labs: Testing the control material using highly accurate and precise reference methods or in reference laboratories to assign target values and ranges before it is marketed.
- Internal validation: Extensive testing by the manufacturer to define its own performance characteristics (like precision and stability), which are then compared to its intended use and regulatory requirements.
The document implies this "ground truth" through the "Mean" values provided in the table, which are the expected values for the control.
8. The sample size for the training set
Not applicable. This device is a quality control material, not an AI/machine learning algorithm that requires a training set. The "precision study" described is a performance validation, not a training process.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.